Trauma-adapted Yoga in Child & Adolescent Psychiatry.

NCT06330779 | Recruiting

• 1 other identifier: UWest
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics, in the population of adolescents with the diagnosis of ADHD and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health \& quality of life of adolescents with ADHD and/or PTSD. (2) Investigate the feasibility of online TAY for continued self-care. (3) Explore adolescents' experiences \& parental perspectives on TAY in their treatment. (4) Explore healthcare professionals' experience on the integration of TAY into clinical practice. Within and between group (yoga group vs waiting list) analyses will be performed.

Conditions

ADHD; PTSD; Quality of Life; Self-Control; Pain; Affect

Outcome Measures

Primary Outcomes (3)

• Negative experience score CPSS-5-S

  Child PTSD Symptom Scale: 27-item self-report version rates each item from 0 (not at all) to 4 (6 or more times a week/almost always) based on the frequency and severity of the reported symptom experienced during the last month. The total severity score ranges from 0 to 80 and is calculated by summing the ratings of the first 20 items. The CPSS-5 also yields subscale scores for intrusion (Items 1-5), avoidance (Items 6-7), changes in cognition and mood (Items 8-14), and increased arousal and reactivity (Items15-20). Finally, seven items assess impairment of endorsed symptoms on daily functioning pertinent to youth (e.g., fun things you want to do, doing your chores, relationships with your friends). The respondent rates these items on a scale of 0 (not at all) to 4 (6 or more times a week/almost always), resulting in an impairment score that ranges from 0 to 28.

  8 weeks

• Inattention, impulsivity score

  Parent-rated ADHD score, SNAP-IV: The SNAP-IV consists of a total of 26 questions, divided into two subscales: one for inattention symptoms and one for hyperactivity-impulsivity symptoms. Each subscale contains 9 items, and there are 8 additional questions that provide an overall assessment of impairment. Higher score indicates higher problem load.

  8 weeks

• Resilience score

  social, ecological, psychological, and emotional resilience: The Child and Youth Resilience Measure-Revised-Adapted Swedish (CYRM-R-AS) is a self-report measures of social ecological and psychological, emotional resilience. In addition to an overall score of resilience, scores can be derived for the three subscales of the measures personal, caregiver and psychological/emotional resilience. The CYRM-R (simplified) is suitable for youth aged 10-23 with difficulties to comprehend text or sustain attention. Its 23 items can be scored on 3- point Likert scales. The items in the measure are all positively worded and therefore scoring involves simple summing of responses. It can be used to evaluate the efficacy of interventions to build and maintain resilience. Three sub-scales can be created . Higher scores indicate better outcome.

  8 weeks

Secondary Outcomes (4)

• Pain frequency and intensity

  8 weeks

• affect

  8 weeks

• Self-directednes

  8 weeks

• Quality of life score

  8 weeks

Study Arms (2)

Yoga-group

EXPERIMENTAL

8 weeks ,once a week, instructor led trauma-adapted yoga intervention.

Other: Trauma-adapted yoga

Controll

NO INTERVENTION

Waiting list

Interventions

Trauma-adapted yoga OTHER

Trauma-adapted-yoga (TAY) classes The classes, which span eight weeks with a once-a-week frequency, each last approximately 45-50 minutes. These small group classes are structured in a semi-circle arrangement to create a sense of security and empowerment for the participants. The teaching approach is trauma-sensitive, characterized by its inviting nature, provision of choices when facing challenges (A-B choices), and direction toward tangible physical sensations to enhance interoceptive awareness. Each yoga session follows a structured sequence of activities designed to promote participants' well-being and physiological awareness. Online TAY classes After eight weeks, adolescents in the yoga group can continue their practice online. Exclusive to previous in-person participants, they'll receive a link for recorded classes and they will have the possibility to contact their health care contact any time.

Yoga-group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents who have received a diagnosis (not under evaluation) of PTSD and/or ADHD
• Understanding English or Swedish languages.

You may not qualify if:

• Ongoing substance use,
• active manic periods,
• psychotic disorders,
• suicidality,
• cognitive impairment.
• serious physical illness prohibiting participation in physical activities.

Sponsors & Collaborators

• University West, Sweden: lead
• Vastra Gotaland Region: collaborator
• Healthcare Region Dalarna: collaborator

Study Sites (1)

Queen Sylvia Child Hospital , CAP

Gothenburg, Sweden

RECRUITING

Related Links

• The project's home page that includes this study as well.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Stress Disorders, Post-Traumatic; Self-Control; Pain

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Social Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nóra Kerekes, Ph.D

CONTACT

+46739013403; nora.kerekes@hv.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 26, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of data collection and analyses, and after we coudl publish the results in peer reviewed scientific journals

Locations

SE (1)